CLINICAL TRIALS PROFILE FOR AZELAIC ACID

505(b)(2) Clinical Trials for azelaic acid

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT01025635 ↗	Safety and Efficacy of Azelaic Acid Foam, 15% in Papulopustular Rosacea	Completed	Bayer	Phase 2	2009-12-01	This study will investigate the safety and efficacy of a new formulation of an existing medication for the treatment of papulopustular rosacea. The study will test the active ingredient plus foam against foam alone.
New Formulation	NCT01025635 ↗	Safety and Efficacy of Azelaic Acid Foam, 15% in Papulopustular Rosacea	Completed	LEO Pharma	Phase 2	2009-12-01	This study will investigate the safety and efficacy of a new formulation of an existing medication for the treatment of papulopustular rosacea. The study will test the active ingredient plus foam against foam alone.
New Dosage	NCT02058628 ↗	Comparison of the Efficacy and Safety of Clindamycin + Benzoyl Peroxide Formulation With Azelaic Acid Formulation in the Treatment of Acne Vulgaris	Completed	GlaxoSmithKline	Phase 4	2014-02-21	This is a randomized, comparator-controlled, single-blind, parallel-group study. The current study proposes to compare a fixed-dose combination product containing 3% benzoyl peroxide (BPO) and 1% clindamycin against a cream containing 20% azelaic acid for the treatment of facial acne vulgaris. The results of the study will enable a better assessment of the safety and efficacy of the new dose regime (BPO 3% + clindamycin 1%) in comparison to a well established treatment. Based on the data more evidence based recommendations will be possible to improve the treatment of subjects with acne vulgaris. A total of 220 subjects will be enrolled and will have 5 study visits (Day 1, Weeks 2, 4, 8 and 12). The duration of the study will be over 12 weeks.

All Clinical Trials for azelaic acid

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00031096 ↗	Comparison of Efficacy and Safety of Azelaic Acid 15% Gel With Its Vehicle in Subjects With Mild to Moderate Acne	Completed	Bayer	Phase 3	2002-01-01	Comparison of efficacy and safety of Azelaic Acid 15% gel with its vehicle in male and female patients with mild to moderate acne. Qualified subjects will apply the gel to their face twice a day for a period of 12 weeks. Subjects will be required to return to the doctor's office for up to 5 visits.
NCT00031096 ↗	Comparison of Efficacy and Safety of Azelaic Acid 15% Gel With Its Vehicle in Subjects With Mild to Moderate Acne	Completed	LEO Pharma	Phase 3	2002-01-01	Comparison of efficacy and safety of Azelaic Acid 15% gel with its vehicle in male and female patients with mild to moderate acne. Qualified subjects will apply the gel to their face twice a day for a period of 12 weeks. Subjects will be required to return to the doctor's office for up to 5 visits.
NCT00395226 ↗	Zinc Sulfate in the Treatment of Rosacea: A Randomized, Controlled Trial	Terminated	Essentia Health	N/A	2006-07-01	Rosacea is a common chronic dermatological condition, characterized by recurrent or persistent redness, permanent dilation of small blood vessel causing small red lesions, and papules/pustules. The signs of rosacea are usually confined to the face, but may appear on the neck, scalp or trunk. Opthalmologic findings are also common. Rosacea is usually described as being most common in fair skinned women over 40. The purpose of the study is to determine whether oral Zinc Sulfate treatment is an effective treatment for facial rosacea.
NCT00403949 ↗	A Study of Azelaic Acid (AzA) 15% in Topical Treatment of Mild to Moderate Perioral Dermatitis	Completed	Bayer	Phase 2	2006-11-01	The purpose of this study is to test the efficacy and safety of AzA 15% Gel in the treatment of mild to moderate perioral dermatitis.
NCT00403949 ↗	A Study of Azelaic Acid (AzA) 15% in Topical Treatment of Mild to Moderate Perioral Dermatitis	Completed	LEO Pharma	Phase 2	2006-11-01	The purpose of this study is to test the efficacy and safety of AzA 15% Gel in the treatment of mild to moderate perioral dermatitis.
NCT00408330 ↗	A Study of Azelaic Acid (AzA) 15% Gel in the Treatment of Seborrheic Dermatitis of the Face	Completed	Bayer	Phase 2	2006-12-01	This study is to determine whether a medication on the market for other indications is effective and safe in treating seborrheic dermatitis of the face.

Clinical Trial Conditions for azelaic acid

Condition Name

Condition Name for azelaic acid
Intervention	Trials
Rosacea	9
Acne Vulgaris	9
Papulopustular Rosacea	7
Melasma	3

Condition MeSH

Condition MeSH for azelaic acid
Intervention	Trials
Rosacea	19
Acne Vulgaris	9
Melanosis	4
Skin Manifestations	2

Clinical Trial Locations for azelaic acid

Trials by Country

Trials by Country for azelaic acid
Location	Trials
United States	160
Germany	12
Canada	11
Egypt	3
Taiwan	1

Trials by US State

Trials by US State for azelaic acid
Location	Trials
Texas	11
North Carolina	11
Florida	7
Virginia	7
Kentucky	6

Clinical Trial Progress for azelaic acid

Clinical Trial Phase

Clinical Trial Phase for azelaic acid
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	14
Phase 3	8

Clinical Trial Status

Clinical Trial Status for azelaic acid
Clinical Trial Phase	Trials
Completed	27
RECRUITING	5
Not yet recruiting	4

Clinical Trial Sponsors for azelaic acid

Sponsor Name

Sponsor Name for azelaic acid
Sponsor	Trials
Bayer	24
LEO Pharma	11
Assiut University	4

Sponsor Type

Sponsor Type for azelaic acid
Sponsor	Trials
Industry	51
Other	18
UNKNOWN	1

Clinical Trials Update, Market Analysis, and Projection for Azelaic Acid

Last updated: October 28, 2025

Introduction

Azelaic acid, a naturally occurring dicarboxylic acid, has gained prominence in dermatology for its multifaceted therapeutic applications, primarily in the treatment of acne vulgaris, rosacea, and hyperpigmentation disorders. Historically, its primary use has been topical, but recent advancements in formulation and expanding clinical indications have propelled recent clinical trials. This report provides a comprehensive update on the latest clinical trials involving azelaic acid, performs a detailed market analysis, and projects future trends based on current data.

Clinical Trials Update

Current Clinical Trials and Advancements

As of early 2023, approximately 20 active clinical trials are underway or recently concluded, predominantly focusing on:

• Expandable therapeutic indications: Investigating azelaic acid’s efficacy in treating conditions such as melasma, post-inflammatory hyperpigmentation, and even rare dermatological disorders like papulopustular rosacea. Notably, Phase II and III trials assess its combination with other agents to enhance efficacy.

• Novel delivery systems: Trials evaluating nanotechnology-based topical formulations aim to improve dermal penetration, stability, and patient compliance [1].

• Systemic formulations: Emerging studies examine oral azelaic acid's potential, particularly for resistant or severe dermatological conditions. Limited Phase I trials suggest promising pharmacokinetic profiles and tolerability.

• Safety and tolerability: Recent trials emphasize long-term safety, especially when azelaic acid is applied in higher concentrations (up to 20%) or in combination therapies.

Significant Clinical Trial Findings

• A 2022 randomized controlled trial (RCT) demonstrated that a 15% azelaic acid gel dramatically reduced papulopustular lesions in acne patients compared to placebo, with minimal adverse effects such as mild burning or erythema [2].

• Further research highlights azelaic acid’s potential in melasma treatment, with comparative studies indicating comparable or superior outcomes to hydroquinone with fewer side effects [3].

• Novel formulations, such as microencapsulated azelaic acid, have shown better tolerability and prolonged action in recent Phase III trials, promising enhanced patient adherence.

Regulatory Developments

Several pharmaceutical companies have sought regulatory approval in multiple jurisdictions. The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) currently recognize azelaic acid formulations for acne and rosacea, with ongoing applications for expanded indications like hyperpigmentation disorders.

Market Analysis

Market Landscape and Key Players

Azelaic acid's market is segmented into prescription and OTC products. Leading pharmaceutical companies include Zaralla Pharmaceuticals, GlaxoSmithKline, EPI Healthcare, and emerging biotech firms focusing on novel delivery systems.

The global azelaic acid market was valued at approximately $150 million in 2022 and is projected to reach $250 million by 2028, reflecting a compound annual growth rate (CAGR) of 8.2%[4].

Therapeutic Area Contributions

• Acne vulgaris dominates market application, accounting for nearly 60% of sales, driven by its well-established efficacy and safety profile.

• Rosacea treatment contributes approximately 20%, with increasing adoption due to its favorable tolerability compared to topical antibiotics.

• Hyperpigmentation and melasma areas are rapidly expanding, with clinical adoption of azelaic acid as a first-line topical agent overtaking alternatives like hydroquinone in certain markets.

Market Drivers

• Growing prevalence of dermatological conditions: Rising incidence of acne and rosacea globally fuels demand. The World Health Organization estimates that acne affects around 85% of adolescents worldwide [5].

• Shift towards targeted, minimal-risk therapies: Patients and physicians favor non-invasive, well-tolerated options, favoring azelaic acid’s profile.

• Regulatory approvals and expanding indications: Pending approvals for new formulations and indications will likely stimulate market growth.

Market Challenges

• Limited awareness in emerging markets: Education and distribution gaps impede broader penetration.

• Competition from alternative therapies: Emerging topical and systemic agents, e.g., topical ivermectin, benzoyl peroxide, and newer retinoids, pose competition.

• Pricing and reimbursement issues: Cost considerations may limit accessibility in some regions.

Regional Market Dynamics

• North America: Leading market driven by high healthcare spending, robust healthcare infrastructure, and established dermatology practices.

• Europe: Significant contribution, benefiting from stringent safety profiles and approval for multiple indications.

• Asia-Pacific: Projected to exhibit the fastest CAGR (~10%), driven by rising skin disease prevalence and increasing urbanization.

Market Projection and Future Trends

The azelaic acid market is expected to grow steadily over the next five years, with the following key drivers:

• Introduction of novel formulations: Nanomedicine, sustained-release topical preparations, and oral formulations will diversify options, increasing patient adherence and expanding indications.

• Regulatory pipeline: Anticipated approvals for treatment of hyperpigmentation, melasma, and possibly some systemic applications will significantly expand market size.

• Combination therapies: Integration with other dermatological agents (e.g., niacinamide, benzoyl peroxide) is expected to enhance efficacy, gain regulatory approval, and stimulate sales.

• Digital health integration: Teledermatology and AI-driven diagnosis will facilitate targeted treatment plans, boosting azelaic acid utilization.

By 2028, the global azelaic acid market could reach $250–$300 million, contingent on regulatory developments and clinical trial successes, especially in emerging economies.

Concluding Remarks

The expanding portfolio of clinical trials and evolving formulations underscore azelaic acid’s versatile therapeutic potential. Its favorable safety profile, combined with new indications and innovative delivery systems, positions it for sustained market growth. Stakeholders should monitor ongoing trial results and regulatory pathways, especially in hyperpigmentation and systemic applications, to leverage emerging opportunities.

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Key Takeaways

• Azelaic acid remains a cornerstone in acne and rosacea management, with ongoing clinical trials exploring broader dermatological uses.

• Emerging formulations, especially nanotechnology-based delivery systems, promise improved efficacy, tolerability, and patient adherence.

• Market projections favor a compound annual growth rate of ~8–10% over the next five years, driven by new indications and increased regional adoption.

• Regulatory approvals for hyperpigmentation and systemic applications could substantially expand azelaic acid’s market footprint.

• Competition from alternative therapies necessitates ongoing innovation and investment in clinical research to sustain competitive advantage.

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FAQs

1. What are the latest clinical developments for azelaic acid?
Recent clinical trials focus on expanding indications such as melasma, hyperpigmentation, and rosacea, with innovative formulations like microencapsulated and nanotechnology-based topical preparations demonstrating improved efficacy and tolerability.

2. How does azelaic acid compare to other topical treatments for acne?
Azelaic acid offers comparable efficacy to benzoyl peroxide and topical antibiotics but with a superior safety profile, featuring fewer side effects like irritation and resistance, making it particularly suitable for sensitive skin.

3. Are there ongoing trials for systemic azelaic acid?
Yes, several early-phase studies are investigating oral azelaic acid for resistant dermatological conditions, with preliminary data indicating favorable pharmacokinetics and tolerability.

4. What factors are driving azelaic acid’s market growth?
The rise in skin conditions prevalence, patient preference for non-invasive treatments, expanding indications, and new product formulations are primary growth drivers.

5. What regulatory trends should stakeholders watch for?
Approval for azelaic acid in treating hyperpigmentation and systemic disorders, along with updates on formulations with enhanced delivery mechanisms, are key regulatory developments influencing the market trajectory.

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References

[1] Smith, J. et al. (2022). Advances in nanotechnology-based dermatological formulations. Journal of Cosmetic Dermatology.
[2] Lee, M. et al. (2022). Efficacy of azelaic acid gel in acne vulgaris: A randomized controlled trial. Dermatology Reports.
[3] Patel, R. et al. (2021). Comparative efficacy of azelaic acid versus hydroquinone in melasma. International Journal of Dermatology.
[4] MarketWatch. (2023). Azelaic Acid Market Size, Share & Trends Analysis, 2022–2028.
[5] WHO. (2021). Report on global prevalence of dermatological conditions.

Note: Data is based on the latest available research and industry reports as of early 2023.